Tagged with USA

USA Dan Leonard, president and CEO of the Association for Accessible Medicines (AAM) since August 2020, outlines his key agenda priorities as head of the USA’s largest generic industry body, how the COVID-19 pandemic has altered the discussion around generics and essential medicines, and his hopes for the Biden administration  …

USA PhRMA’s Stephen J. Ubl outlines two ways in which the new US presidency can help lower healthcare costs and why biopharmaceutical companies support changes to the system that can lower US patients’ out-of-pocket spending and continue to drive innovation.   By bringing an end to the pandemic and lowering out-of-pocket…

USA With Rare Disease Day coming up on February 28th, one of the leading organizations dedicated to serving affected patients in the US, the National Organization for Rare Disorders (NORD), is making a push to put the spotlight on the limited access to diagnosis, treatment and care suffered by rare disease…

USA The AAM’s Dan Leonard highlights the savings impact that generic and biosimilar medicines have on US healthcare today and introduces the ‘Secure Our Meds’ campaign which aims to educate policymakers on the importance of generic and biosimilar market competition and how it can be safeguarded.   More than 35 years…

USA Following on from our profile on five of the most promising clinical-stage biotech companies developing orphan therapies in Europe, here we move to the world’s biggest biopharmaceutical market and R&D hub, shining the spotlight on five of the most important and innovative rare-disease start-ups in the USA.   The US…

USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients.   The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…

China Dr Liang Schweizer introduces immunotherapy-focused biotech HiFiBiO Therapeutics, the main advantages of the company’s unique single-cell technology platform, its open innovation approach, experience with capital markets, and advice for other biotech leaders.   The traditional bulk analysis method is well-established and suited for diseases that are more homogenous, but cancer…

USA Dr Maria T. Millan, president and CEO of the California Institute for Regenerative Medicine (CIRM), shares the Institute’s mission to advance basic and translational research in regenerative medicine in the State of California, their unique funding and operating model, and her perspective on the critical importance of investment in science…

USA Certara’s Ulrich Neumann examines some of the major US market access trends of the past few years, including the innovative financing models required for novel therapies, why cost effectiveness considerations are on the rise, and the impact of the drug policy environment on payer sentiments.   The US reimbursement landscape…

Global David H. Crean summarizes the recent 39th annual J.P. Morgan Healthcare Conference 2021 that was held in a virtual format, noting potential changes in format for future events. Crean does, however, underline the importance of the Conference for industry networking and highlights some of the biopharma topics to watch under…

USA Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain…

Norway Photodynamic therapy (PDT) firm Photocure is probably Norway’s most significant recent international healthcare success story. CEO Dan Schneider explains how the company was able to action a more effective global commercial strategy and carve out a niche in the relatively uncrowded oncology drug-device combination market.   Despite its technology being…